483
Children's National Medical Center IRBFDA 483 - Children's National Medical Center IRB - June 06, 2019
Record Details
The FDA inspected Children's National Medical Center IRB and found significant deficiencies in their operations. The IRB failed to promptly report instances of serious non-compliance and study suspensions to the FDA. Additionally, the IRB did not consistently meet quorum requirements for convened meetings and failed to maintain accurate and complete membership rosters.
Open in Dashboard
ID · c3864a46-56f0-4bd6-b51c-502cb15b2a6c